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Current Openings
| Position: Instrumentation Engineer |
Apply here |
Role :
- Assists the Clinical and Bioanalytical operations to provide GLP support on maintenance, calibration and validation of instruments.
Experience :
- Minimum 4-5 years in CRO/regulated environment/Pharmaceutical companies
Responsibilities :
- Ensure smooth functioning of instruments in coordination with supplier.
- Ensure proper connectivity of Analyst & LC Solutions software with machine.
- Maintain the proper functioning of central monitoring system (EDMS).
- Maintain stock for spear part and inventory.
- Calibration of all equipments according to the SOP.
- Perform preventive maintenance and ensure general cleaning of all equipments and maintain the calibration schedules.
- Select and audit external calibrating agencies for calibration of critical instruments.
- Maintain environmental condition in the LAB.
- Electrical maintenance and power backup equipments.
- Updating SOPs time to time as per requirement and according to GLP.
- Perform and maintain all the documents related to IQ/OQ/PQ/ calibration / validation, certificate/Malfunction.
- Troubleshooting and maintenance of all equipments used in facility.
- Coordinate with vendors to reduced breakdown time of instruments.
- Maintain maximum uptime by making system more redundant.
- Maintenance of air compressor and ensure appropriate gas supply in the LAB.
- Maintenance of Synchronized digital clocks used in the facility
- Ensure proper documentation and facilitate periodic internal audit and regulatory inspections.
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| Manager – Business Development - 01 Post |
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Role :
- To identify business contacts, prepare marketing material and requests for proposal. To assists Vice President - BD & Clinical Trial Operations in coordinating the day-to-day logistics.
Responsibilities :
- To develop marketing materials this will include website, brochures, banners/ back-drops and power-point presentations
- To prepare the list of important domestic and international conferences and working toward the registration for short listed conferences
- Coordinating with different vendors for stall arrangements and other logistics for participation in the conference
- To prepare templates for preparing request for proposals for different services
- To identify sales leads and contacts and to prepare proposals for submission to clients
- Regular updates of the Pharma and CRO industry to the BD group
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| Senior Medical Officer – Qualification - MD - Pharmacology - 01 Post |
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Role :
- Assists the Head- Clinical Operations in the maintenance of the ward infrastructure and in efficiently planning and executing the logistics of all clinical studies at the CRO.
Responsibilities :
- To prepare protocols and informed consent forms (ICFs) for clinical studies
- To ensure that the studies are carried out as per protocol and applicable regulatory requirements of GCP
- To impart training on protocol GCP, GLP and technical aspects
- To provide ICF presentation to volunteers and answer queries
- To organize work schedules and supervise the activities of paramedical staff
- To maintain a database of contractual medical and paramedical staff
- To monitor and manage adverse events during the study
- To interact with the hospital authorities and ensure availability and readiness of ICU at all times
- To ensure the accurate compilation of raw data and prepare clinical reports
- To write and revise SOPs for general or clinical activities and maintain adherence to all current SOPs
- To supervise the activities of Nursing Staff and Medical Officers for rendering medical services to the subjects at the Clinical Section
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| Medical Officer (Screening) – Qualification MBBS - 01 Post |
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Role :
- Assists Head Clinical Operations in standardization and review of screening procedures and conduct of clinical studies at the Clinical Section by timely recruitment of volunteers.
Responsibilities :
- To review medical screening records and ascertain suitability of subjects
- To conduct clinical examination of all subjects participating during all clinical Studies
- Volunteer selection, informed consent procedure as per defined procedure
- To monitor safety parameters during all clinical studies
- To compile clinical raw data for all the clinical studies conducted at Clinical Section
- To write and revise SOPs and ensure compliance with all current policies and procedures
- To compile and assist in the analysis of raw data
- To assist in conducting ICF presentation and answer queries
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